Autologous T Cell Immunotherapy for Chronic Lymphocytic Leukemia (CLL) Patients

Exclusion Criteria

• •Evidence of Richter's Syndrome, T cell CLL, prolymphocytic leukemia, hairy-cell leukemia, splenic lymphoma with villous lymphocytes, large granular lymphocytosis, Sezary-cell leukemia, adult T-cell leukemia/lymphoma, or leukemic manifestations of non-Hodgkin's lymphoma
• •Receipt of any chemotherapy, monoclonal antibody, investigational, or other systemic therapy for the treatment of CLL within 2 months prior to registration.
• •Receipt of glucocorticoids (with the exception of inhaled glucocorticoid steroids for the use of allergic rhinitis or pulmonary disease) within 2 months prior to registration
• •Receipt of intravenous immunoglobulin (IVIG) within 1 month of registration
• •Registration for, or plans to participate in, any other clinical trial concurrently for the duration of this trial
• •History of malignancy other than CLL within five years of registration, except adequately treated basal or squamous cell skin cancer or in situ carcinoma of the cervix. Other exceptions must be approved by the Xcyte Therapies' Medical Monitor prior to registration.
• •Infection requiring treatment with antibiotics, antifungal, or antiviral agents within seven days of registration
• •Liver disease or hepatitis as reflected by a serum bilirubin or ALT \> 2.0 times the upper limit of normal laboratory range within 15 days of registration
• •Compromised renal function as reflected by a serum creatinine \> 2 times the upper limit of normal laboratory range within 15 days of registration
• •History of autoimmune disease unrelated to CLL (e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosis). Autoimmune disease related to CLL, e.g. idiopathic thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia, is permitted if treatment with steroids has not been required in the two months prior to registration. Hypothyroidism without evidence of Grave's Disease or Hashimoto's thyroiditis is permitted.
• •Major organ system dysfunction including (but not limited to): New York Heart Association Class III or IV (Appendix B, page 51), pulmonary disease requiring the use of inhaled steroids or bronchodilators, renal, hepatic, gastrointestinal, neurologic, or psychiatric dysfunction which would impair patient's ability to participate in the trial
• •Evidence of infection with HIV 1 or 2, HTLV 1 or 2
• •Evidence of acute or active chronic Hepatitis B or C infection
• •Positive human anti-mouse antibody (HAMA) test as performed at the central reference laboratory designated by the sponsor